Class Class I

Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl (K223859)

K223859 2023-02-13 Traditional
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Description

Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl by Rhino Health, Inc., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK223859
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeLZA
Regulation Number880.6250

Categories

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Predicate lineage for K223859

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl (K223859) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K221082Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwi...Rhino Health, Inc.2022

Trace the full predicate network for K223859

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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